EPHEDRINE HYDROCHLORIDE INJECTION 30MG IN 1 ML

PDF Transcript

• you are currently taking or have taken within the last 14 days
any monoamine oxidase inhibitor medicine used to treat
depression.
Other medicines and Ephedrine Injection
Tell your doctor, pharmacist or nurse if you are taking, have
recently taken, or might take any other medicines.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ephedrine Hydrochloride 30mg per 1ml Solution for Injection
Ephedrine Hydrochloride
(Referred to as “Ephedrine Injection” in this leaflet)

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Read all of this leaflet carefully before you are given this
medicine because it contains important information for
you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor,
pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Ephedrine Injection is and what it is used for
What you need to know before you are given Ephedrine
Injection
How Ephedrine Injection is given
Possible side effects
How to store Ephedrine Injection
Contents of the pack and other information

1. What Ephedrine Injection is and what it is used
for
Ephedrine belongs to a group of medicines called
sympathomimetics. Sympathomimetic drugs affect the part of
your nervous system that works automatically.
Ephedrine Injection is used to relieve low blood pressure during
spinal or epidural anaesthesia. It raises blood pressure by
temporarily reducing the blood supply to small blood vessels.

THE FOLLOWING INFORMATION IS INTENDED FOR
HEALTHCARE PROFESSIONALS ONLY

Dose
Adults and the elderly
Up to 30 mg in increments of 3 - 7.5 mg.
By slow intravenous administration, after development
of hypotension.
Children
0.5-0.75mg per kg of body weight or 17-25mg per square metre
of body surface area. By slow intravenous administration, after
development of hypotension.
Contra-indications:
This medicinal product must never be used in case of
hypersensitivity to ephedrine.
• In combination with other indirect sympathomimetic
agents such as phenylpropanolamine, phenylephrine,
pseudoephedrine and methylphenidate.
• In combination with alpha sympathomimetic agents.
• In combination with non-selective MAO inhibitors or within 14
days of their withdrawal.

2. What you need to know before you are given
Ephedrine Injection
You should not be given Ephedrine Injection if:
• you are allergic to ephedrine hydrochloride or to any of the
other ingredients in this medicine, (listed in section 6).
• you are taking another indirect sympathomimetic agent such
as phenylpropanolamine, phenylephrine, pseudoephedrine
(medicines used to relieve blocked nose) or methylphenidate
(medicine used to treat “attention deficit hyperactivity
disorder (ADHD)”)
• you are taking an alpha sympathomimetic agent (medicines
used to treat low blood pressure)
• you are taking or have taken in the last 14 days a non-selective
monoamine oxidase inhibitor (medicines used to
treat depression)
Warnings and precautions
Talk to your doctor before using Ephedrine Injection if:
• you suffer from diabetes
• you suffer from heart disease or any other heart conditions,
including angina;
• you suffer from weakness in a blood vessel wall leading to a
bulge developing (aneurysm);
• you have high blood pressure;
• you have a narrowing and/or blockage of blood vessels
(occlusive vascular disorders)
• you have an overactive thyroid gland (hyperthyroidism);
• you know or suspect that you suffer from glaucoma (increased
pressure in your eyes) or prostatic hypertrophy (enlarged
prostate gland);
• you are about to have an operation which requires that you are
given an anaesthetic;
Warnings:
Ephedrine should be used with caution in patients who may
be particularly susceptible to their effects, particularly those
with hyperthyroidism. Great care is also needed in patients
with cardiovascular disease such as ischaemic heart disease,
arrhythmia or tachycardia, occlusive vascular disorders including
arteriosclerosis, hypertension, or aneurysms. Angina pain may be
precipitated in patients with angina pectoris.
Care is also required when Ephedrine is given to patients
with diabetes mellitus, closed-angle glaucoma or prostatic
hypertrophy.
Ephedrine should be avoided or used with caution in patients
undergoing anaesthesia with cyclopropane, halothane, or
other halogenated anaesthetics, as they may induce ventricular
fibrillation. An increased risk of arrhythmias may also occur
if Ephedrine is given to patients receiving cardiac glycosides,
quinidine, or tricyclic antidepressants.
Many sympathomimetics interact with monoamine oxidase
inhibitors, and should not be given to patients receiving such
treatment or within 14 days of its termination. It is advisable to
avoid sympathomimetics when taking selective MAO inhibitors.

Ephedrine Injection must not be used with drugs used to treat
severe depression, such as phenelzine or moclobemide, or if
you are within 2 weeks of discontinuing them. These drugs are
known as monoamine oxidase inhibitors (MAOIs).
Other medicines which may interact with Ephedrine
Injection are:
• methylphenidate, used to treat “attention deficit hyperactivity
disorder (ADHD)”;
• indirect stimulators of the sympathetic nervous system such as
phenylpropanolamine or pseudoephedrine (medicines used in
nasal decongestant), phenylephrine (a medicine used to treat
hypotension);
• direct stimulators of alpha receptors of the sympathetic
nervous system (oral and/or nasal use) that are used to treat
hypotension or nasal congestion, among others;
• anaesthetics that are inhaled, such as halothane;
• medicines used to treat depression;
• sibutramine, a medicine used as an appetite suppressant;
• linezolid, used to treat infections;
• medicines used to treat asthma such as theophylline
• corticosteroids, a type of medicine used to relieve swelling in a
variety of different conditions;
•medicines for epilepsy;
• doxapram, medicines used to treat breathing problems;
• oxytocin, a medicine used during labour;
• reserpine and methyldopa and related medicines, used to treat
high blood pressure;
• guanethidine and related medicines, used to treat high blood
pressure;
• Ergot alkaloids, a type of medicines used as vasoconstrictors
(narrowing blood vessels) or for their dopaminergic action
(increasing the dopamine-related activity in the brain).

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor, pharmacist or
nurse for advice before being given this medicine.
Laboratory Testing
This medicinal product contains an active ingredient that can
induce positive results in anti- doping controls.

3. How Ephedrine Injection is given
This medicine is an injection and will be given to you by your
doctor. Your doctor will determine the dose you require.
The recommended doses are:
Adults, elderly and children over 12 years:
The usual starting dose is 3-7.5mg given slowly into a vein.
Your dose may be repeated until the maximum amount of
medicine (30mg) is given.
Use in children:
The paediatric dose will be given as a slow injection into the
vein of either 0.5-0.75mg per kg of body weight or 17-25mg per
square metre of body surface area.
Patients with kidney or liver disease:
There are no dose adjustments recommended for patients with
kidney or liver disease.
If you have any further questions on the use of this medicine, ask
your doctor, pharmacist or nurse.
If you think you have been given too much Ephedrine
Injection
This medicine is given to you by your doctor so it is unlikely you
will receive too much. Your doctor has information on how to
recognise and treat an overdose. If you are concerned about your
treatment, please talk to your doctor.
If you have any further questions on the use of this product, ask
your doctor or nurse.
Continued overleaf

Hypokalaemia associated with high doses of beta2 agonists
may result in increased susceptibility to digitalis-induced
cardiac arrhythmias. Hypokalaemia may be enhanced by
concomitant administration of aminophylline or other xanthines,
corticosteroids, or by diuretic therapy.

Guanethidine and related products
Substantial increase in blood pressure (hyper reactivity linked
to the reduction in sympathetic tone and/or to the inhibition of
adrenaline or noradrenaline entry in sympathetic fibres).

If the combination cannot be avoided, use with caution lower
doses of sympathomimetic agents.
Sibutramine
Paroxysmal hypertension with possibility of arrhythmia
(inhibition of adrenaline or noradrenaline entry in sympathetic
fibres).
Halogenated volatile anaesthetics

Ephedrine increases blood pressure and therefore special care
is advisable in patients receiving antihypertensive therapy.
Interactions of Ephedrine with alpha- and beta-blocking drugs
may be complex. Propranolol and other beta-adrenoceptor
blocking agents antagonise the effects of beta2 adrenoceptor
stimulants (beta2 agonists) such as salbutamol.

Selective MAO-A inhibitors (administered concomitantly or
within the last 2 weeks)
Risk of vasoconstriction and/or episodes of hypertension.

Theophylline
Concomitant administration of ephedrine and theophylline may
result in insomnia, nervousness and gastrointestinal complaints.

Linezolid
Risk of vasoconstriction and/or episodes of hypertension

Corticosteroids

Adverse metabolic effects of high doses of beta2 agonists may
be exacerbated by concomitant administration of high doses of
corticosteroids; patients should therefore be monitored carefully
when the 2 forms of therapy are used together although this
precaution is not so applicable to inhaled corticotherapy.

Ephedrine has been shown to increase the clearance of
dexamethasone.
Antiepileptics: increased plasma concentration of phenytoin and
possibly of phenobarbitone and primidone.
Doxapram: risk of hypertension.
Continued overleaf

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100mm Measurement Verification Bar

4. Possible side effects
Like all medicines Ephedrine Injection can cause side effects,
although not everybody gets them.

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Possible side effects include:
If you get any of the following side effects, stop taking this
medicine and seek urgent medical advice straight away:
• difficulty in breathing
• abnormal heart rhythm;
• palpitations, high blood pressure, fast heartbeat, or
• pain over the heart, slow heartbeat, low blood pressure;
• heart failure (cardiac arrest);
• bleeding in the brain;
• build up of a fluid within the lungs (pulmonary oedema);
• increased pressure in the eye (glaucoma)
• difficulty in passing urine
Other side effects that you may experience while taking this
medicine are:
Common (may affect up to 1 in 10 people):
• confusion, feeling worried, depression;
• nervousness, irritability, restlessness, weakness, sleeping
problems, headache, sweating
• shortness of breath;
• nausea, vomiting
Not Known (frequency cannot be estimated from the available
data):
• affects blood clotting,
• allergy (hypersensitivity);
• changes in your personality or the way you feel/think; fear
• tremor; excessive saliva production
• reduced appetite;
• a decrease in blood potassium levels; changes in blood
sugar levels

Oxytocin: hypertension with vasoconstrictor sympathomimetics.
Hypotensive agents: reserpine and methyldopa may reduce the
vasopressor action of ephedrine.
Pregnancy:
Studies in animals have shown a teratogenic effect.
Clinical data from epidemiological studies on a limited number of
women appear to indicate no particular effects of ephedrine with
respect to malformation.
Isolated cases of maternal hypertension have been described
after abuse or prolonged use of vasoconstrictor amines.
Ephedrine crosses the placenta and this has been associated with
an increase in foetal heart rate and beat-to-beat variability.
Therefore, ephedrine should be avoided or used with caution,
and only if necessary, during pregnancy.
Side effects:
Blood and lymphatic system disorders:
Not known: primary haemostasis modifications
Immune system disorders:
Not known: hypersensitivity
Psychiatric disorders:
Common: confusion, anxiety, depression
Not known: psychotic states, fear
Nervous system disorders:
Common: nervousness, irritability, restlessness, weakness,
insomnia, headache, sweating
Not known: tremor, hypersalivation
Eye disorders:
Not known: episodes of angle-closure glaucoma
Cardiac disorders:
Common: palpitations, hypertension, tachycardia
Rare: cardiac arrhythmias

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme: www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the safety of
this medicine.

5. How to Store Ephedrine Injection
Keep out of the sight and reach of children.
You should not be given this medicine if it has passed the expiry
date shown on the ampoule label and carton after EXP.
This refers to the last day of that month. Your doctor or nurse will
check this.
Do not store above 25°C. Keep in the outer carton in order to
protect from light. This medicine will only be used for your
treatment. Your doctor will dispose of any left over medicine.

6. Contents of the pack and other information
What Ephedrine Injection contains
The active ingredient is Ephedrine Hydrochloride 3%w/v,
equivalent to 30mg ephedrine hydrochloride in 1ml solution
ampoule.
The other ingredient is water for injections.
What Ephedrine Injection looks like and contents of the pack
Ephedrine Injection is a clear, colourless solution for injection
supplied to your doctor or pharmacist in a pack of 10 clear glass
ampoules, each containing 1ml of medicine.

Overdose:
Symptoms
In the event of overdose, the occurrence of nausea, vomiting,
fever, paranoid psychosis, ventricular and supraventricular
arrhythmias, hypertension, respiratory depression, convulsions
and coma is observed.
The lethal dose in humans is approximately 2 g corresponding to
blood concentrations of approximately 3.5 to 20 mg/l.
Treatment
The treatment of ephedrine overdose with this product
may require intensive supportive treatment. Slow
intravenous injection of labetalol 50-200mg may be given
with electrocardiograph monitoring for the treatment
of supraventricular tachycardia. Marked hypokalaemia
(<2.8mmol.l-1) due to compartmental shift of potassium
predisposes to cardiac arrhythmias and may be corrected by
infusing potassium chloride in addition to propranolol and
correcting respiratory alkalosis, when present.

Ephedrine is asympathomimetic amine acting directly on
the alpha and beta receptors and indirectly by increasing the
release of noradrenaline by the sympathetic nerve endings.
As with any sympathomimetic agent, ephedrine stimulates
the central nervous system, the cardiovascular system, the
respiratory system, and the sphincters of the digestive and
urinary systems. Ephedrine is also a monoamine oxidase (MAO)
inhibitor.

Incompatibilities:
In the absence of compatibility studies, this medicinal product
must not be mixed with other medicinal products.
Shelf life:
3 years unopened. Do not store above 25°C. Keep in outer
carton. This is a potent drug, which should be stored carefully.
Do not administer if there are visible signs of deterioration.
This product is for single use only. If only part of the solution is
used the remainder should be discarded.
Authorisation holder:
MaCarthys Laboratories Ltd T/A Martindale Pharma
Bampton Road,
Romford,
RM3 8UG
England
Authorisation numbers: PL 01883/6131R
This leaflet was last revised in: December 2016

Pharmaco-kinetics:
After intravenous administration, ephedrine is completely
biologically available, and after oral administration, the
bioavailability of ephedrine has been reported to be above 90%.
Excretion depends on urine pH:
From 73 to 99% (mean: 88%) in acidic urine,
From 22 to 35% (mean: 27%) in alkaline urine.
After oral or parenteral administration, 77% of ephedrine is
excreted in unchanged form in the urine.
The half-life depends on urine pH. When the urine is acidified
at pH = 5, the half-life is 3 hours; when the urine is rendered
alkaline at pH = 6.3, the half-life is approximately 6 hours.
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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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